Cognitive Training to Enhance Brain Concordance During Acupuncture

NCT06157866 | Recruiting DMC

• 1 other identifier: 2023P003155
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the impact of a novel non-pharmacological multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. This study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia.

Conditions

Fibromyalgia

Keywords

hyperscan fmri; hyperscan EEG; acupuncture; fibromyalgia; chronic pain

Outcome Measures

Primary Outcomes (1)

• Brain Imaging-fMRI

  Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician.

  Up to 6 months

Secondary Outcomes (1)

• Brain Imaging-EEG

  Up to 6 months

Other Outcomes (1)

• Brief Pain Inventory (BPI) - Pain Interference

  Up to 6 months

Study Arms (2)

Cognitive Training

EXPERIMENTAL

Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.

Other: Electroacupuncture; Behavioral: Cognitive Training

Education Training

ACTIVE COMPARATOR

Participants will meet with a pain specialist to receive education training related to fibromyalgia.

Other: Electroacupuncture; Behavioral: Education Training

Interventions

Electroacupuncture OTHER

During the treatment sessions the acupuncturist will insert needles in several locations aimed to reduce the patient's fibromyalgia pain. A low-amplitude, sub-sensory electrical current will be activated by the acupuncturist.

Cognitive Training; Education Training

Cognitive Training BEHAVIORAL

Cognitive training with a pain specialist.

Cognitive Training

Education Training BEHAVIORAL

Education training with a pain specialist.

Education Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet traditional American College of Rheumatology (ACR) criteria for FM as well as the more recent Wolfe et al 2011 criteria
• Are on stable doses of medication for 30 days prior to entering the study and agree not to change medications or dosages during the trial
• Ability to fully understand and consent to study procedures
• Baseline pain intensity of at least 4/10
• Pain duration of at least 6 months

You may not qualify if:

• Any longer period of work experience involving pain treatment, pain rehabilitation etc.
• Presence of any illness that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual
• Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
• History of significant head injury
• Inability to respond accurately to the pain-relieving intervention in the behavioral part of the experiment, indicating a lack of response to the expectancy manipulation. If the healthy volunteer or clinician is not a responder to the behavioral expectancy induction he or she will be excluded.
• Unwillingness to receive brief experimental pain.
• Leg pain or health issues that may interfere with the study procedures.
• Comorbid acute pain condition
• Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
• Current use of opioid analgesics
• Concurrent inflammatory or autoimmune disease
• Documented peripheral neuropathy
• Pregnant
• Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, bipolar disorder, severe personality disorders)
• History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Electroacupuncture; Cognitive Training; Sex Education

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Neurological Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Sexology; Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Vitaly Napadow, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seneca Ellis

CONTACT

617-952-6484; sellis11@mgb.org

Arvina Grahl, PhD

CONTACT

agrahl@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: December 6, 2023
• Study Start: February 16, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)